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Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-Compulsive Disorder
This study is not yet open for participant recruitment.
Study NCT00723060   Information provided by Seoul National University Hospital
First Received: July 24, 2008   Last Updated: July 25, 2008   History of Changes

July 24, 2008
July 25, 2008
 
 
The difference of Y-BOCS score average from baseline to 16-week [ Time Frame: baseline and16-week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00723060 on ClinicalTrials.gov Archive Site
1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A [ Time Frame: every 2 week ] [ Designated as safety issue: No ]
Same as current
 
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-Compulsive Disorder
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-Compulsive Disorder (Randomized, Double-Blind, Multi-Center Study)

OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD).

OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind, Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS: Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S & -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events / Serious Adverse Events, UKU

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Obsessive Compulsive Disorder
Drug: escitalopram
  • Active Comparator: escitalopram high dose group
  • Active Comparator: escitalopram conventional group
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
166
 
 

Inclusion Criteria:

  1. Man or woman, aged 18 to 65 years, outpatient
  2. Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months
  3. Severity: Y-BOCS score of >= 20 at screening and baseline
  4. No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening
  5. Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration.

Exclusion Criteria:

  1. primary active DSM-IV axis I diagnosis other than OCD
  2. History of substance, including alcohol, dependence and psychotic symptoms
  3. Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of >17 at screening or baseline
  4. Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity
  5. History of no response to escitalopram or citalopram treatment
  6. History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening
  7. Women who are pregnant, planning to become pregnant, or breast-feeding
  8. Ongoing cognitive behavior therapy (CBT) of OCD
  9. Hoarding or collecting type
  10. Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)
Both
18 Years to 65 Years
No
Contact: Jun Soo Kwon, M.D., Ph.D. kwonjs@snu.ac.kr
Korea, Republic of
 
NCT00723060
Seoul National University Hospital, Seoul National University Hospital
11769A
Seoul National University Hospital
 
Principal Investigator: Jun Soo Kwon, M.D., Ph.D. Seoul National University Hospital, Seoul, Korea
Seoul National University Hospital
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP